A Multicenter Research on the Effects of Substitution of Hospital Ward Care From Medical Doctors to Physician Assistants
13 мая 2015 г. обновлено: Radboud University Medical Center
Worthy Assistants: Does Substituting Hospital Ward Care From Medical Residents to Physician Assistants Result in Cost Savings?
Reallocation of healthcare is one solution to the problems healthcare is facing. In the Netherlands reallocation of care to Physician Assistants (PAs) hasn't adequately been studied. Given the growing number of PAs, it is essential to evaluate the effectiveness and efficacy of (Dutch) PA services.
This multicenter matched-controlled study aims to evaluate the (cost) effectiveness of substitution of hospital ward care from medical doctors (MDs) to PAs. The traditional model in which the role of house officer is taken by medical doctors MD model) will be compared with a mixed model in which a PA functions as house officer together with a medical doctor (PA/MD model). Hospital wards will be matched on medical specialism and hospital type (i.e. academic;non-academic). On the basis of USA studies, it is hypothesized that the mixed PA/MD model compared to the MD model reduces the costs of healthcare, while improving or maintaining the clinical outcomes, patients and provider satisfaction, and continuity and quality of care.
Primary research question:
• What is the effect of 'mixed PA/MD model' compared with 'MD model' on efficiency of care?
Secondary research questions:
- What is the effect of 'mixed PA/MD model' compared with 'MD model' on clinical and patients outcomes?
- What is the effect of 'mixed PA/MD model' compared with 'MD model' on continuity of care?
- What is the effect of 'mixed PA/MD model' compared with 'MD model' on nurses and (specialist) medicals doctor experiences?
- What are the barriers and facilitating factors considering the implementation of PAs as house officer?
Обзор исследования
Тип исследования
Наблюдательный
Регистрация (Действительный)
2382
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Utrecht, Нидерланды
- UMC Utrecht
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Drenthe
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Emmen, Drenthe, Нидерланды
- Scheper Ziekenhuis
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Friesland
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Heerenveen, Friesland, Нидерланды, 8441 PW
- Tjongerschans Ziekenhuis
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Gelderland
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Apeldoorn, Gelderland, Нидерланды
- Gelre Ziekenhuizen
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Arnhem, Gelderland, Нидерланды, 6800 TA
- Rijnstate
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Doetinchem, Gelderland, Нидерланды
- Slingeland Ziekenhuis
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Ede, Gelderland, Нидерланды
- Ziekenhuis de Gelderse Vallei
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Nijmegen, Gelderland, Нидерланды, 6500HB
- Radboud University Nijmegen Medical Centre
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Nijmegen, Gelderland, Нидерланды, 6532 SZ
- Canisius Wilhelmina Ziekenhuis
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Winterswijk, Gelderland, Нидерланды
- Streekziekenhuis Koningin Beatrix
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Limburg
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Roermond, Limburg, Нидерланды, 6043 CV
- Laurentius ziekenhuis
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Roermond, Limburg, Нидерланды
- Laurentius ziekenhuis
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Sittard, Limburg, Нидерланды
- Orbis Medisch Centrum
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Venlo, Limburg, Нидерланды, 5912 BL
- VieCuri Medical Center
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Noord-Brabant
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Bergen op Zoom, Noord-Brabant, Нидерланды, 4624 VT
- Lievensberg ziekenhuis
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Den Bosch, Noord-Brabant, Нидерланды
- Jeroen Bosch Ziekenhuis
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Helmond, Noord-Brabant, Нидерланды
- Elkerliek Ziekenhuis
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Roosendaal, Noord-Brabant, Нидерланды, 4708 AE
- Fransiscus Ziekenhuis
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Tilburg, Noord-Brabant, Нидерланды
- St. Elisabeth Ziekenhuis
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Tilburg, Noord-Brabant, Нидерланды
- TweeSteden Ziekenhuis
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Zeeland
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Dirksland, Zeeland, Нидерланды
- Van Weel Bethesda Ziekenhuis
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Zuid-Holland
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Delft, Zuid-Holland, Нидерланды
- Reinier de Graaf Gasthuis
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Den Haag, Zuid-Holland, Нидерланды
- HagaZiekenhuis
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Den Haag, Zuid-Holland, Нидерланды
- Medisch Centrum Haaglanden
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Невероятностная выборка
Исследуемая популяция
Hospital Ward Care: all patients (age 18 years or older) admitted to a hospital ward will be included in the study.
Описание
Inclusion criteria:
• Wards using a mixed PA/physician model (with PA ward coverage of at least 50% of the available ward hours per week, during dayshifts on weekdays) or a physician model (daily coverage by a (specialized medical doctor)
Exclusion criteria on ward level:
- Wards from specialty hospitals
- Wards with only PAs in training
- Wards with a nurse practitioner (NP) in the role of house officer (NP, NP/MD or PA/NP/MD model)
- Pediatric and psychiatric wards, intensive care units
Exclusion criteria on patient level:
- Terminal patients
- Not fluent in Dutch language
- Age < 18 years
- Patients in daycare
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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MD model
Hospital wards at which ward care is provided only by Medical Doctors (MDs)
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PA/MD model
Hospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs)
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Intervention wards are hospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs)
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Length of hospital stay
Временное ограничение: Patients will be followed for the duration of hospital stay; an expected average of 6 days
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The difference between date of discharge and date of admission
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Patients will be followed for the duration of hospital stay; an expected average of 6 days
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Efficiency of care
Временное ограничение: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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Relevant costs associated with the principal admission (length of hospital stay, resource use, consultation of health care suppliers, salaries) and costs that occurred after discharge (unplanned readmission, presentation at emergency departments, visits of general practitioner, required home care) will be calculated, considering a follow-up period from admission until 1 month after discharge.
All volumes will be collected in detail at an individual patient level, primarily from medical patient records and patient and care provider questionnaires.
Medical costs will be calculated by multiplying the volumes of healthcare use with corresponding unit prices, derived from the Dutch Manual for Costing Research
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Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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Quality of hospital ward care
Временное ограничение: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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To estimate the quality of ward care, a set of objective indicators has been developed through literature review and clinical input from a physician panel.
We have selected both clinical indicators and process indicators, with a follow-up period of maximum 1 month after discharge.
Clinical indicators were based on the national set of indicators for quality of hospital care from the Dutch Health Care Inspectorate (IGZ) and consider the incidences of inhospital mortality, cardiopulmonary resuscitation, unplanned readmission, presentation at emergency department after discharge,unplanned transfer to Intensive Care Unit, development of hospital infections, pressure sore and fever, and pain scores .
Process indicators are the number of days between a patients discharge and the date of written turnover to general practitioner or other hospital, and acquaintance with the patient within 24 hours after admission
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Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days
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Patient quality of life
Временное ограничение: Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days. Measurements of quality of life will be performed at hospital admission, hospital discharge and 1 month after discharge
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Patient experienced quality of life will be measured by the EQ-5D questionnaire.
This questionnaire will be distributed at hospital admission, hospital discharge, and 1 month after discharge
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Patients will be followed from hospital admission till 1 month after discharge; an expected average of 1 month and 6 days. Measurements of quality of life will be performed at hospital admission, hospital discharge and 1 month after discharge
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Feasibility, barriers and facilitators
Временное ограничение: 12 months
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Semi-structured (group)interviews will be held with PAs, (specialized) medical doctors, ward nurses and heads of the departments.
The interviews will cover experiences with the utilized ward model, communication between professionals, satisfaction, and barriers and facilitators related to the utilization of the 'mixed PA/MD model'.
Specific attention will be paid to the role and functioning of PAs
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12 months
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Care provider experiences
Временное ограничение: 12 months
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Job satisfaction, subjective workload and stress reaction of PAs, (specialized) medical doctors and ward nurses will be measured by a self-administered questionnaire. Job satisfaction will be measured by an adapted version of the job satisfaction questionnaire of McCranie, stress reaction will be measured by a short version of the General Health Questionnaire (GHQ-12) Objective workload will be measured by calculating the ratio between number of working hours at the hospital ward, and the number of patients the PA or medical doctor is responsible for. |
12 months
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Continuity of care
Временное ограничение: 4 months
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Continuity of care will be measured by deriving the number of rotations of PAs and medical doctors at the hospital ward from work schedules, which will be assessed during 4 weeks, spread over 4 months
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4 months
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Patient experiences with hospital ward care
Временное ограничение: Patients will be followed for the duration of hospital stay; an expected average of 6 days. Measurement of patient experiences will be performed at discharge
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Patient experiences with medical ward care will be assessed by a self-administered questionnaire at discharge.
This questionnaire focuses on satisfaction with communication, experienced continuity of care and cooperation, and the patients view on the medical competencies of the ward care provider
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Patients will be followed for the duration of hospital stay; an expected average of 6 days. Measurement of patient experiences will be performed at discharge
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: M.G.H. Laurant, PhD, IQ healthcare, UMC St Radboud
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Timmermans MJC, van Vught AJAH, Peters YAS, Meermans G, Peute JGM, Postma CT, Smit PC, Verdaasdonk E, de Vries Reilingh TS, Wensing M, Laurant MGH. The impact of the implementation of physician assistants in inpatient care: A multicenter matched-controlled study. PLoS One. 2017 Aug 9;12(8):e0178212. doi: 10.1371/journal.pone.0178212. eCollection 2017.
- Timmermans MJC, van den Brink GT, van Vught AJAH, Adang E, van Berlo CLH, Boxtel KV, Braunius WW, Janssen L, Venema A, van den Wildenberg FJ, Wensing M, Laurant MGH. The involvement of physician assistants in inpatient care in hospitals in the Netherlands: a cost-effectiveness analysis. BMJ Open. 2017 Jul 10;7(7):e016405. doi: 10.1136/bmjopen-2017-016405.
- Timmermans MJ, van Vught AJ, Van den Berg M, Ponfoort ED, Riemens F, van Unen J, Wobbes T, Wensing M, Laurant MG. Physician assistants in medical ward care: a descriptive study of the situation in the Netherlands. J Eval Clin Pract. 2016 Jun;22(3):395-402. doi: 10.1111/jep.12499. Epub 2015 Dec 23.
- Timmermans MJ, van Vught AJ, Wensing M, Laurant MG. The effectiveness of substitution of hospital ward care from medical doctors to physician assistants: a study protocol. BMC Health Serv Res. 2014 Jan 28;14:43. doi: 10.1186/1472-6963-14-43. Erratum In: BMC Health Serv Res. 2016;16(1):115.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 апреля 2013 г.
Первичное завершение (Действительный)
1 мая 2015 г.
Завершение исследования (Действительный)
1 мая 2015 г.
Даты регистрации исследования
Первый отправленный
5 апреля 2013 г.
Впервые представлено, что соответствует критериям контроля качества
18 апреля 2013 г.
Первый опубликованный (Оценивать)
19 апреля 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
14 мая 2015 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
13 мая 2015 г.
Последняя проверка
1 мая 2015 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 80-82310-97-12094
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .